Adaptive Optics Retinal Imaging
Food and Drug Administration (FDA)
Summary
The objective of the study is to collect and assess adaptive optics (AO) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of AO technology.
Description
Objective: The objective of the study is to collect and assess adaptive optics (AO) retinal images from human subjects in support of projects to demonstrate, advance, and enhance clinical use of AO technology. Study Population: One hundred (100) healthy volunteers without eye disease and fifty (50) subjects with primary open angle glaucoma (POAG) will be enrolled. Design: This is an interventional study protocol where participants will be imaged with investigational multimodal AO retinal imaging systems that include optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO) c…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Are 21 years of age or older. 2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam). 3. Have the ability to understand and sign an informed consent. 4. Have been diagnosed with POAG (cohort 2). Exclusion Criteria: 1. Are under 21 years of age. 2. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity). 3. Have visual correction outside of the range +4 diopters (D) to -8 D. 4. Have a history of adverse reaction to mydriatic drops.…
Interventions
- Otheroxygen inhalation
Subjects will breath 100% oxygen through a mask.
- DeviceAdaptive optics imaging
Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging
Location
- Food and Drug AdministrationSilver Spring, Maryland